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Saturday morning, National Cancer Institute Director Richard Klausner, MD, welcomed attendees to the ASCO annual meeting by also welcoming them into what he sees as a new era for oncology: the so-called "post-genomic era." With the completion of the draft sequence of the human genome three months ago, said Klausner, we passed a "remarkable milestone" that will change all areas of medicine?"but none more rapidly than oncology."

While there is still much more work to be done, Klausner asserted that the decoding of the human genome will profoundly change?and is already changing?the way that oncologists understand and treat cancer. And he made his strong sense of optimism evident as he sketched out an overview of its likely impact over the next decade and beyond.

"This will do for biology and medicine what the periodic table did for chemistry one hundred years ago," said Dr. Klausner. "It will allow a new way to look at cell processes, so that we can view systems comprehensively, and identify new patterns. And it will dramatically speed up the somewhat stochastic process of molecular discovery of the past three decades."

Now that we've read the genome, Klausner stressed, we need to decipher it, because the ability to decipher pathways will profoundly change how we describe the "wiring" of cells and then understand how and where the "misfiring" that produces cancer cells occurs. As that happens, oncologists will be able to characterize the different gene expression patterns? or "lineages"?that can be associated with the same form of cancer. And this will allow them to classify diseases into further subtypes.

This information will be critical in determining why certain treatments work well on some people and not on others. It also holds great promise for the development of treatments with certain molecular targets?that is, treatments that target what is happening at the most basic molecular level to cause the cancer.

"This will profoundly change every aspect of determining risk, how treatments are developed, and how physicians and patients choose treatment," he added. "And this is a profound change that we're all going to have to struggle with and rise to." For example, instead of thinking of cancers by their site of origin (where they occur), it may very well become more useful to describe them by their molecular profile (how they occur), as characterized by gene expression analysis.

Klausner used the example of the FDA's recent approval of STI-571 for chronic myeloid leukemia to illustrate what he meant by the promise of molecular understanding of disease. "Here's an agent that targets a fully credentialed molecular cause of this type of cancer and 51 out of 53 patients showed an incredible immune response," he said. STI-571, a "signal transduction inhibitor," blocks a particular gene product that has been associated with the development of the disease.

As more and more "maps" of human cancers are developed thanks to knowledge gained through the Human Genome Project, he predicted, more and more treatments that target the critical junctures in those maps will follow.

Klausner noted that at least two dozen clinical trials have recently opened or are in the works for other molecular targets. "We must continue to fully credential such targets and develop treatments accordingly."

"More and more," he added, "this will be the face of how you design and look for holes in your clinical trials and anti-cancer drugs."

Klausner noted that education of physicians and patients will be imperative as well, since the challenges of the post-genomic era will not be limited to the lab. "This will affect our language, our perception, and our approach to the care of patients," Klausner said, and he noted that the NCI plans to use its CancerNet and cancerTrials Web sites as educational tools.

"We are entering a remarkable new era of human history and discovery. It's going to take all of us looking, speaking, exploring and communicating, and working together to learn to live in this exciting post-genomic era," Klausner concluded.